The invention relates to orthotic devices which may be used in the emergency treatment of bone fractures. More particularly, the invention relates to orthotic devices for partial or substantial immobilization of bone fractures, and particularly pelvic fractures, in emergency rooms of hospitals, at an accident site or in transit from an accident site, where quick and effective stabilization of a fracture is essential and where such a device must be adapted both to the dimensions of the individual and the body part being treated.
A common method of treating fractures in the field or at an accident scene is to determine the nature and general extent of the injury and thereafter attempt to immobilize the fractured body part to avoid further injury to the patient, should the body part be moved. Although it may be appropriate to immobilize bone fractures of a limb with a cast arrangement at an accident scene, because of the nature of the type of materials used to form such casts and the time required to apply and subsequently remove the cast when the patient reaches the hospital or other treatment facility, it is generally not feasible to attempt to immobilize pelvic fractures by such means. In addition, without the benefit of x-ray pictures of the injured area, the fracture could be improperly immobilized, causing additional harm. Little more can be done in the field since the means to produce x-ray pictures of the fracture at the accident scene are currently unavailable. Should the patient be bleeding, additional steps may be taken to arrest bleeding.
Although exceptions exist, the time elapsed between the occurrence of the fracture of a limb and the subsequent treatment of the limb in a modern medical facility does not result in a life threatening situation as long as the treatment in such a facility is not unduly delayed, the patient has not lost a large volume of blood, and initial emergency treatment has been administered in the interim. However this is not true of bone fractures in other parts of the body, particularly in the pelvic region.
Tens of thousands of pelvic fractures occur each year. Most of these injuries result from motor vehicle collisions, falls from height, or other industrial accidents. Many of these injuries are life threatening with serve blood loss from torn blood vessels or bleeding from fractured pelvic bones. Even with hairline pelvic fractures, blood loss may be significant since the pelvis bones are very porous.
Heretofore, emergency treatment for these injuries has required the application of a pelvic external fixator. To properly apply the device, pins must be drilled into the pelvic bones and connected to a frame by clamps. Accordingly, successful application of a pelvic external fixator requires experienced personnel and frequently X-ray fluoroscopic control. Usually these devices are applied in the operating room of a hospital. Presently, there is no means of stabilization of pelvic fractures by emergency medical service technicians for transport of the patients from the accident scene.
Thus, a need exists for a device and a method of rapidly immobilizing a fractured bone and particularly a fractured pelvic bone. A need also exists for a method and device which can be used to supply sufficient pressure at the site of the fracture to arrest any bleeding that accompanies the fracture, particularly a fractured pelvic bone. Any device and method used for such purposes should, preferably, also be easily and quickly administered to the patient with little regard to the dimensions of the patient or the strength of the medical treatment personnel. In addition, a significantly higher skill level should not be required of the emergency personnel applying such a device to a patient suffering from a bone fracture than is generally required from such personnel at the present time in treating the same type of fracture. Preferably, the device should be capable of being left in place both during the early stages of emergency treatment and through initial assessment of the degree of injury and proposed treatment. This would include conducting an x-ray examination and, accordingly, preferably, the device should not include any radio-opaque materials. In addition, the device should be preferably so constructed and formed from such materials as to permit the device to conform to the profile and the dimensions of the part of the body to which it is applied. Accordingly, except where a stay or splint type of article is to be operatively associated with the device, no rigid parts should be incorporated into the device. Preferably, the device should also apply pressure substantially equally to all surfaces of the portion of the body which it contacts.
It is an object of the invention to provide orthoses and a method of using such orthoses to rapidly immobilize a fractured bone, particularly a fractured pelvic bone. It is a further object of the present invention to employ a single orthotic device to permit custom fitting of the device to patients and body parts of different sizes. It is an additional object to provide an orthotic trauma device and a method of using the same which can provide sufficient pressure at the site of the injury to arrest bleeding accompanying a bone fracture. It is an object of this invention to provide an orthotic device which can be easily and quickly administered to a patient with little regard to the dimensions of the patient or the strength of the medical treatment personnel treating the patient. More specifically, it is a primary object of this invention to provide orthoses which may be tightened around the fractured bone of a patient to provide the necessary support with minimal physical effort required on the part of the emergency medical treatment personnel. It is yet another object of the present invention to provide apparatus having a significant mechanical advantage that may be individually adjusted to a desired tension and conformity to an individual patient""s dimensions. In addition, it is an object of the invention to require a skill level of the emergency personnel applying such a device to a patient suffering from a bone fracture which is not significantly higher than is generally required from such personnel at the present time in treating the same type of fracture using currently available means for such treatment.
It is still another object of the present invention to provide device which may be left in place on the patient during the early stages of emergency treatment through initial assessment of the degree of injury and proposed treatment. It is a further object of the invention that all of the components of the device be radio-lucent.
The present invention relates to a device and a method of rapidly immobilizing a fractured bone and particularly a fractured pelvic bone. The invention also provides a method and device which can be used in most instances to supply sufficient pressure at the site of the fracture to arrest bleeding that may accompany the fracture. The device of the invention may be easily and quickly applied to the patient with little regard to either the dimensions of the patient or the strength of the medical treatment personnel applying the device to the patient. The skill level required of the emergency personnel applying such a device to a patient suffering from a bone fracture is generally not significantly more than that required from such personnel at the present time in treating the same type of fracture. The device of the invention may be left in place both during the early stages of emergency treatment and through initial assessment of the degree of injury and proposed treatment. This includes conducting an x-ray examination and, accordingly, preferably, the device is free of radio-opaque materials. In addition, the device of the invention is so constructed and is formed from such materials as to permit the device to conform to the profile and the dimensions of the part of the body to which it is applied. Accordingly, except where a stay or splint type of article is to be operatively associated with the device, no rigid parts are incorporated into the device.
The orthotic trauma device is suitable for use in the emergent treatment of most types of bone fractures and preferably pelvic fractures. Compression of the pelvis with this orthotic device stabilizes the broken bones of the pelvis and helps control blood loss by reducing the volume that can be bled into. Reducing the motion of the bone fragments allows bleeding sites to clot off helping to limit blood loss as well as greatly improving the comfort of the patient. Use of this device lessens the likelihood of further injury to nerves, blood vessels or internal organs when the patient is moved. These devices can easily be applied at the accident scene by emergency medical technicians or in an emergency room. These devices provide sufficient provisional stabilization of the pelvis that the need for emergent application of a pelvic external fixator is eliminated in most cases.
This device does not interfere with the systematic evaluation of the trauma patient in the emergency room. It is preferably radiolucent and allows X-rays, CT scans, and angiography, abdominal ultrasound, peritoneal lavage, etc. to be carried out with the device in place. If need be it can be removed and reapplied easily. It can be left in place in most cases until workup is compete and definitive open reduction and internal fixation of the pelvic fracture can be performed.
The orthotic devices of the present invention, include an orthosis body or bracing portion, in the shape of a wide belt, adapted to be wrapped around a portion of a body of a user, the bracing portion being elongated and formed from a material which is easily cut with cloth-cutting scissors and is also, preferably, formed from a material which is radiolucent (i.e., non-radiopaque). A detachable fastening device is provided at the distal or outer ends of the elongated bracing portion to detachably secure the ends around the part of the body where the bone fracture is located. The fastening device is preferably provided with a means for adjusting the tightness or tension of the bracing portion, accomplished preferably by increasing the mechanical advantage of the fastening device. Preferably the means for increasing the mechanical advantage of the fastening device is a detachable pulley system which includes a pair of pulley banks. A first bank of the pulley system is detachably disposed on a first distal end of the elongated bracing portion and a second pulley bank is detachably disposed on a second distal end of the elongated bracing portion. A cable is operatively connected to the two pulley banks such that the first and second banks of the pulley system are in juxtaposed relationship. The cable runs through a pulley on each juxtaposed pulley bank in series and in alteration, shortening of the cable pulling the two banks of pulleys and concomitantly the opposed ends of the orthosis body together and tightening the orthotic device with the aid of mechanical advantage dependent upon the number of pulleys mounted in the pulley bank on each opposing orthosis body end.
In a preferred embodiment, each set of pulleys comprises two modular banks of pulleys which are detachably secured to opposing free ends of the same bracing portion. A cable is provided to connect pulleys in the opposing banks of pulleys in a set in series and in alteration. The ends of each cable preferably may be joined to form an endless cable or are attached to a handle which also achieves the effect of an endless cable. Preferably, the handle also may be removed from the body of the device when the modular banks of the pulley set are removed.
The orthotic device of the invention is easy to apply when used to immobilize most bone fractures. When used for immobilizing most pelvic fractures, the device can be placed on the exam table or gurney before the patient is placed thereon or it can be slid underneath the patient""s hips. The belt may then be cut to the proper length with a scissors, such as the type commonly used in cutting adhesive tape and gauze. Preferably, when placed on the patient, there should be a gap of about of six inches at the front of the device between the belt or free ends of the orthosis body. The removable fastener is then detachably secured to each of the free ends of the orthosis body and suitably tightened to provide the appropriate amount of compression. In a preferred embodiment of the invention which employs a mechanism that increases the mechanical advantage of the fastening device, such as a pulley system which includes two banks of pulleys, each bank is then put in place on a respective belt end using a suitable fastener, such as a hook-and-loop means of attachment. The pulley system is then cinched tight and secured. Because of the combination of the orthosis body or belt of the invention and the characteristics of the fastening system employed, particularly the preferred pulley system of the invention, including both the structural features thereof and the materials used in the construction of the component parts, the orthotic trauma device achieves xe2x80x9cisobaric compressionxe2x80x9d, when tightened, meaning that the device applies substantially uniform pressure to all surfaces of the body with which it contacts. Since the belt or bracing portion itself is made of a soft material and the device provides isobaric compression, it can be left in place for a considerable length of time without causing pressure problems to the skin.
To improve appropriate immobilization when used to isolate a bone fracture located other than in the pelvic region, an embodiment of the present invention may include a rigid splint or stay, preferably held removably in place in the bracing portion. Preferably, the splint or stay would be disposed within a pocket in the bracing portion.